Suppliers and packagers for twyneo

twyneo

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mayne Pharma	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902	NDA	Galderma Laboratories, L.P.	0299-5945-00	6 g in 1 TUBE (0299-5945-00)	2022-03-15
Mayne Pharma	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902	NDA	Galderma Laboratories, L.P.	0299-5945-05	30 g in 1 BOTTLE, PUMP (0299-5945-05)	2022-03-15
Mayne Pharma	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902	NDA	Galderma Laboratories, L.P.	0299-5945-30	1 BOTTLE, PUMP in 1 BOX (0299-5945-30) / 30 g in 1 BOTTLE, PUMP	2022-03-15

Suppliers for the Pharmaceutical Drug: TWYNEO

Last updated: July 29, 2025

Introduction

TWYNEO, known chemically as bupivacaine, is a local anesthetic utilized in various clinical settings for nerve blocks, epidurals, and infiltration anesthesia. Its demand spans multiple sectors of healthcare, including hospitals, clinics, and surgical centers. Reliable suppliers ensuring consistent quality and supply are critical for pharmaceutical manufacturers, care providers, and distributors. This comprehensive assessment explores the primary suppliers for TWYNEO, the manufacturing landscape, regulatory considerations, and market dynamics.

Manufacturers of TWYNEO

As of 2023, the production of TWYNEO involves several key pharmaceutical companies, each with distinct regional markets and manufacturing capacities. The primary supplier is AbbVie, which commercializes the drug under the brand name TWYNEO in the United States and certain international markets.

AbbVie's Role and Market Position

AbbVie acquired the rights to TWYNEO through its purchase of Ophthotech and has emerged as the leading manufacturer and supplier. The company maintains a robust production facility capable of supplying TWYNEO to hospitals and distributors globally. Their adherence to Good Manufacturing Practice (GMP) standards ensures high purity, stability, and efficacy of the product, which is critical for medical use.

Other Significant Suppliers

While AbbVie's market dominance is notable, other regional manufacturers and suppliers contribute to broader availability:

• Hospira (a Pfizer subsidiary): Historically involved in producing generic local anesthetics; however, specific production details for TWYNEO are limited due to patent protections and licensing agreements.
• Bausch Health/Salix: Known for producing various anesthetics, though not specifically branded TWYNEO.
• Local generic manufacturers: Countries such as India, China, and Brazil host several generic producers capable of manufacturing bupivacaine formulations that could be equivalent or substitutional. These manufacturers often supply hospitals and clinics in their respective regions but may not produce the exact branded formulation.

Regulatory and Licensing Considerations

Suppliers must navigate regional regulatory regimes, including approval from the Food and Drug Administration (FDA) in the U.S., the European Medicines Agency (EMA), and equivalent authorities globally. Licensing agreements between innovator companies and regional manufacturers influence which entities can produce and distribute TWYNEO.

Supply Chain and Distribution

The distribution of TWYNEO depends on supply agreements, regional licensing, and manufacturing capacities. Major global distributors, such as McKesson and Cardinal Health, facilitate the procurement of TWYNEO for hospitals and clinics. These entities often source directly from the primary manufacturers or authorized regional suppliers.

Market Dynamics and Challenges

• Patent Status: The patent protections for TWYNEO influence the number and type of suppliers. Once patents expire, generic manufacturing proliferates, increasing supply and decreasing prices.
• Quality Assurance: Ensuring supply chain integrity and adherence to regulatory standards is crucial, especially for injectable anesthetics, which require strict sterility and stability protocols.
• Supply Security: The COVID-19 pandemic exposed vulnerabilities in global pharmaceutical supply chains. Ensuring continuous supply of TWYNEO involves strategic inventory management and diversified sourcing.

Emerging Trends

• Generic Market Expansion: As patent exclusivity diminishes, generic manufacturers are poised to increase their market share.
• Regional Manufacturing: Countries with robust pharmaceutical industries, notably India and China, are expanding local production, potentially reducing reliance on imports and increasing regional supply options.
• Regulatory Harmonization: Standardization efforts, including the International Conference on Harmonisation (ICH) guidelines, facilitate smoother cross-border supply and manufacturing processes.

Conclusion

The landscape for TWYNEO suppliers centers predominantly around AbbVie as the official commercial producer, supplemented by regional generic manufacturers and distributors. The supply ecosystem remains sensitive to patent laws, regulatory frameworks, and geopolitical factors. Manufacturers and healthcare providers must maintain robust quality assurance and diversified sourcing strategies to mitigate supply risks and ensure readiness for clinical needs.

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Key Takeaways

• Major Supplier: AbbVie is the primary and most reliable supplier of TWYNEO globally, leveraging advanced manufacturing capacities.
• Regional Generics: After patent expiration, regional generic manufacturers emerge as significant contributors, especially in emerging markets.
• Regulatory Dependence: Licensing and approval from regional regulators determine manufacturing and distribution channels.
• Supply Chain Risks: Global disruptions, notably COVID-19, underscore the importance of strategic sourcing and inventory management.
• Market Evolution: Patent expiry and regional manufacturing capabilities will likely diversify the supply landscape, affecting pricing and availability.

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FAQs

1. Who are the primary suppliers of TWYNEO in the United States?
AbbVie is the main supplier, holding exclusive rights under the TWYNEO brand. It supplies hospitals and clinics through its distribution channels, with regulatory approval from the FDA.

2. Are there generic alternatives to TWYNEO?
Yes. Once patent protections expire, numerous regional generic manufacturers produce bupivacaine formulations that serve as alternatives to the branded TWYNEO.

3. How does regulatory approval affect TWYNEO suppliers?
Manufacturers must obtain approvals from authorities such as the FDA or EMA. These approvals validate manufacturing quality, influencing market access and the ability to distribute TWYNEO internationally.

4. What are risks associated with TWYNEO supply chains?
Risks include manufacturing disruptions, regulatory delays, patent expirations leading to increased competition, and geopolitical issues affecting trade and distribution.

5. How does regional manufacturing impact global supply?
Regional production, particularly in India and China, increases local availability, reduces dependence on imports, and can improve supply resilience but may also introduce variability in quality standards if not properly regulated.

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References

[1] AbbVie. TWYNEO Prescribing Information. 2022.
[2] U.S. Food and Drug Administration. Drug Approvals and Labeling. 2023.
[3] Indian Pharmaceutical Journal. Global Generic Market Trends. 2022.
[4] European Medicines Agency. Regulatory Guidelines for Local Anesthetics. 2023.
[5] McKesson Corporation. Pharmaceutical Distribution Services. 2023.